Pharmacokinetic Drug-Drug Interaction Study

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether benznidazole and E1224 should be administered concomitantly in patients with Chagas Disease as not enough data are available. This study aims to assess cross interactions of these two compounds.

Clinical Trial Description

Benznidazole and E1224 are intended to be administered concomitantly in patients with Chagas disease. Thus, an in vivo interaction study in healthy volunteers may be justified as the two drugs are intended to be administered concomitantly in patients and no in vivo nor in vitro data are available.

In addition both interactions (potential for benznidazole to interact on the pharmacokinetic (PK) of E1224 and potential for E1224 on the PK of benznidazole should be studied.

Benznidazole t1/2 is quite short (12 h) whereas E1224 t1/2 is very long (more than 200 h). Therefore it was chosen to study the interaction of E1224 at steady-state while interaction of benznidazole after single dose appears more appropriate instead of a classical randomized cross-over design. ;

Study Design

Related Conditions & MeSH terms

Chagas Disease

Clinical Trial Details

NCT number	NCT03892213
Study type	Interventional
Source	Drugs for Neglected Diseases
Contact
Status	Completed
Phase	Phase 1
Start date	October 2014
Completion date	January 2015

View Details

See also
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